Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
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MDR Amendment Proposal Likely To Be Adopted In Two Weeks’ Time
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.
Innovation To Suffer Under Revised MDR Unless Addressed Now, Suggest MDR Proposal Responses
Damage to SMEs and innovation, overly high notified body costs and concerns over lack of surveillance for critical devices are all topics addressed among responses to the European Commission’s latest MDR proposal.
Commenting On the EU MDR Proposal? What You Need To Know About Finer Details
18 January is the deadline to respond to the European Commission’s 6 January proposal to amend the Medical Device Regulation by extending legacy product transition deadlines. This article explains how changes are expected to be made.